Biomea Fusion to Present New Preclinical Data on BMF-219 in Two Diabetic Animal Models at ADA 2022

• Company to host virtual investor R&D event on Monday, June 6, 2022 at 4:05 PM EDT featuring covalent menin inhibitor, BMF-219, as a potential novel treatment for type 2 diabetes

REDWOOD CITY, Calif., June 01, 2022 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced that two abstracts, including a Late-Breaker, were released in conjunction with the American Diabetes Association (ADA) Scientific Sessions.

Collectively, the pre-clinical data presented in the abstracts supports the mechanism of action of BMF-219, reestablishing a pool of functional beta cells via the covalent inhibition of menin and maintaining durable glycemic control. BMF-219 improved beta cell function and insulin sensitivity while maintaining its effects without chronic drug exposure during the observation period.

The company’s first abstract and presentation #113-LB titled, “Oral Menin Inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a Type 2 Diabetes Mellitus Rat Model,” will be presented on Sunday, June 5th from 12pm to 1pm CT in the late breaking poster session. The abstract posted on the ADA website highlights the depth and the durability on HbA1C lowering that BMF-219 achieved preclinically in the Zucker diabetic fatty rat (ZDF) model of diabetes. BMF-219, as a single agent, demonstrated a significant reduction in HbA1C versus liraglutide and strong glucose tolerance and glycemic control. These effects were maintained even after dosing had stopped.

The company’s second abstract and presentation #851-P titled, “Oral Long-Acting Menin Inhibitor Normalizes Type 2 Diabetes Mellitus (T2DM) in Two Rat Models,” will be presented on Sunday, June 5th from 12pm to 1pm CT as part of the general poster session. The abstract highlights the robust effect BMF-219 demonstrated preclinically in the ZDF and the Streptozotocin (STZ) rat model of type 2 diabetes. BMF-219 normalized glucose levels as a single agent through re-establishing functional beta cells in the STZ model, where only direct injection of insulin typically provides glycemic control. BMF-219 maintained this effect to a large degree even after dosing ended. The accepted abstracts are available now for viewing on the ADA website.

A live webcast of Biomea’s virtual investor R&D event on June 6^th at 4:05 pm ET featuring the BMF-219 program in diabetes will be available to registered attendees under the Investors and Media section of the company’s website at https://investors.biomeafusion.com/news-events/events. A replay of the presentation will be archived on Biomea’s site for 14 days following the event.

About Menin in Diabetes

Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function are diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta cell turnover / beta-cell growth, supporting the notion that inhibition of menin could lead to the reestablishing of normal healthy beta cells. Based on these and other scientific findings, Biomea explored the potential for covalent menin inhibition as a viable therapeutic approach to permanently halt or reverse progression of type 2 diabetes.

About Biomea Fusion

Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ System to advance a pipeline of covalent-binding therapeutic agents against key oncogenic drivers of cancer and metabolic diseases. Biomea Fusion’s goal is to utilize its capabilities and platform to become a leader in developing covalent small molecules in order to maximize the clinical benefit when treating various cancers and metabolic diseases.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding our cash runway, the clinical and therapeutic potential of our product candidates and development programs, including BMF-219, the potential of BMF-219 as a treatment for various types of cancer and diabetes, our research, development and regulatory plans, including our pursuit of BMF-219 in metabolic diseases, and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.

Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays or unforeseen results in preclinical development, IND-filing and acceptance, patient enrollment and in the initiation, conduct and completion of our planned clinical trials and other research, development and regulatory activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:

Van Sandwick
Director, Investor Relations & Corporate Development
vsandwick@biomeafusion.com
(650) 460-7759